Application 218873

Type: ANDA
Sponsor: MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PITOLISANT	PITOLISANT	TABLET; FILM COATED	4.45MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A218873-001	PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET / ORAL	AB		2026-08-14
A218873-002	PITOLISANT HYDROCHLORIDE	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET / ORAL	AB		2026-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A218873-001	AB
A218873-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218873-001	PITOLISANT HYDROCHLORIDE	EQ 4.45MG BASE	TABLET / ORAL	AB		2026-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218873-002	PITOLISANT HYDROCHLORIDE	EQ 17.8MG BASE	TABLET / ORAL	AB		2026-08-14	`84e616aacf4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218873-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218873-002	AB	1	`84e616aacf4f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.